Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007345485

FEI Number

3007345485

Entity Name

MICRO-NX CO., LTD.

City/State/Country

Dong-gu Daegu, KR

Establishment Address

22, Maeyeo-ro 1-gil, Dong-gu Daegu 41059, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MICRO-NX Co., Ltd. (Owner Number: 10054332)

Owner / Operator Contact Address

22, Maeyeo-ro 1-gil, Dong-gu, Daegu 41059, Daegu, KR-NOTA 41059, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K232810

PMA Number

N/A

All Registered Proprietary Names

Impla-NX (Model: ISE-270C) Impla-NX (Model: ISE-270M) ELEC-LED (EL-B40I) ELEC-LED (EL-B40L) ELEC-LED (EL-B40S) ELEC-LED (EL-B40M) OSM-TORQ MEG-TORQ TD-C60 Dental Handpiece, Wireless Endodontic Handpiece, endoit (Model: EH-C500)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2021-05-29
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2022-02-07
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2017-03-08
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2023-12-08

Official Correspondent

Jong Kun Lee

US Agent Details

Sunyoung Park Email: sypark@szukorea.com Phone: (682) 7729233

Related Public Records

Same Entity

MICRO-NX Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K040153	Indigenous Peoples Technology and Education Center	I-TEC PORTABLE DENTAL OPERATORY	2004-05-21
K241065	Dentis Co., Ltd.	ChecQ (AC100)	2025-03-21

Similar Registrations

Registration Number	Establishment Name	Location
3014683120	JMU DENTAL, INC	Fullerton, CA, US
2520265	DENTALEZ, INC., STARDENTAL DIVISION	Lancaster, PA, US
3009768364	Foshan CICADA Dental Instrument Co., Ltd.	Foshan Guangdong, CN
9611253	NAKANISHI INC.	Kanuma Tochigi, JP
1054713	TOYO MEDICAL CO.	Doral, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007345485. Last updated year: 2026. Please use registration number 3007345485 when referencing this establishment in official correspondence.